This SOP is provide written guidelines to enumerate the bioload of
Primary packaging materials.
2.0 Scope :
This SOP extends to all primary packing materials like PVC, PVDC film, Aluminium foil, Blister foils, LDPE bags, PP caps, measure cups, glassbottles (amber & clear) & Pet bottles (amber & clear).
3.0 Responsibility :
Microbiologist Q.C & Officer Q.C
4.1.0 By swab method:
Preparation of Media & it composition (Refer SOP No.
Preparation of Swabs (Refer SOP No. QC/MB/).
4.1.1 Collection Sample:
Aluminum Foils , PVC/PVDC Foil and LDPE bags
4.1.2 On receipt of GRN, from stores to Q.C if it is primary packing
material inform to Microbiologist for sampling.
4.1.3 Carry the sterlized Swabs in a stainless steel bin
previously wiped with 70% v/v IPA to the Stores department.
4.1.4 Follow the gowning procedure.
4.1.5 Select the roll to be sampled. Follow √ n +1.
4.1.6 One circular layer of foil is discarded and in next layer an area of approximately 100 sq.cms shall be examined to 10ml sterile saline
4.1.7 In case of P.P.Caps and Measure cups 10 numbers shall be swabbed in to 10 ml sterile saline
4.1.8 Make sure that the samples after examination should be destroyed.
4.1.9 Press the swab with a rolling motion against the side of the glass tube to remove excess liquid with heavy pressure rub back and forth over the area to be examined so that all parts of the surface are covered by swab.
4.1.10 This swab shall be rotated so that all parts of it make contact with the surface to be examined.
4.1.11 The liquid is mixed by swirling the swab vigorously in the solution and remove the swab.
4.1.12 Bring the swabs to microbiology department.
4.2.1 The test must be begin within one hour of the above sampling.
4.2.2 After thorough mixing the swab is examined for Total bacterial count.
4.2.3 1ml of above sample is added individually into 2 sterile petridishes.
4.2.4 Cool the sterlized media to about 45°C.
4.2.5 Add about 15-20ml of SCDA into two petridishes and cover.
4.2.6 Gently rotate the plate clockwise and anticlockwise for uniform mixing of sample and allow to solidify.
4.2.7 Invert the petridishes and incubate the SCDA plates at 30°C to 35°C for 72 hours.
4.2.8 At the end of incubation period count the number of colonies in each plate.
4.2.9 Calculate the TAMC per Swab using the following equation.
( T1 + T2 ) x D / 2 = Y cfu/Swab.
Where T1 + T2 = Sum of duplicates of SCDA plates.
D = Reciprocal of initial dilution ( D= 10 where 10ml the saline)
Y = TAMC
If the TAMC results in a fraction round to the nearest whole number for reporting the final result.
If no growth is found in any of the plates then TAMC must be recorded as <>
4.4.0 Frequency of testing: Once in a year